Oral Rivaroxaban in Children With Venous Thrombosis



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:6 - 17
Updated:7/21/2016
Start Date:February 2013
End Date:September 2016
Contact:Bayer Clinical Trials Contact
Email:clinical-trials-contact@bayerhealthcare.com

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30-day, Single-arm Study of the Safety, Efficacy and the Pharmacokinetic and Pharmacodynamic Properties of Oral Rivaroxaban in Children With Various Manifestations of Venous Thrombosis

The purpose of this study is to find out whether rivaroxaban is safe to use in children and
how long it stays in the body. There will also be a check for bleeding and worsening of
blood clots.


Inclusion Criteria:

- Children aged 6 to < 18 years who have been treated for at least 2 months or, in case
of catheter-related thrombosis, for at least 6 weeks with LMWH (low molecular weight
heparin), fondaparinux and/or VKA (vitamin K antagonist) for documented symptomatic
or asymptomatic venous thrombosis - Hemoglobin, platelets, creatinine and alanine
aminotransferase (ALT) and total bilirubin evaluated within 10 days prior to
randomization

- Informed consent provided and, if applicable, child assent provided

Exclusion Criteria:

- Active bleeding or high risk for bleeding contraindicating anticoagulant therapy

- Symptomatic progression of venous thrombosis during preceding anticoagulant treatment

- Planned invasive procedures, including lumbar puncture and removal of non
peripherally placed central lines during study treatment

- An estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2

- Hepatic disease which is associated with coagulopathy leading to a clinically
relevant bleeding risk or ALT > 5x upper level of normal (ULN) or total bilirubin >
2x ULN with direct bilirubin > 20% of the total

- Platelet count < 50 x 10^9/L

- Hypertension defined as > 95th age percentile

- Life expectancy < 3 months

- Concomitant use of strong inhibitors of both cytochrome P450 isoenzyme 3A4 (CYP3A4)
and P-glycoprotein (P-gp), i.e. all human immunodeficiency virus protease inhibitors
and the following azole antimycotics agents: ketoconazole, itraconazole,
voriconazole, posaconazole, if used systemically

- Concomitant use of strong inducers of CYP3A4, i.e. rifampicin, rifabutin,
phenobarbital, phenytoin and carbamazepine
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